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Description of key information

In a sub-acute gavage study in male and female Wistar rats oral application of up to 1000 mg/kg bw/day (related to dry mass) for 14 days did not result in clinical signs, effects on body weight or food consumption,  in relevant macroscopical changes at necropsy or effects on organ weights.
In a sub-chronic gavage study according to OECD Guideline 408 in male and female Wistar rats no effects of toxicological relevance were detected even at the high dose level of 1000 mg/kg bw/day (related to dry mass).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Mode of Action Analysis / Human Relevance Framework

Additional information

In a subacute 14 -Days dose range finding study with Biofert Plusz, dose levels of 100, 300 and 1000 mg/kg bw/day (related to dry mass) were administered once daily by gavage to Wistar rats of both sexes (n=5 per sex per dose). Parameters investigated were clinical signs, body weights and food consumption, organ weights and macroscopic findings. None of these parameters was changed by the test item at any of the dose levels tested.

Oral administration of undiluted test item via gavage to male and female Wistar rats (n=10 per dose per sex; once weekly, 7 days per week) at dose levels of 100, 300 and 1000 mg/kg bw/day (related to the dry mass corresponding to 0, 356, 1068, 3559 mg/kg bw/day of the liquid test item), for 91 days resulted in no mortality, no clinical signs (daily or weekly), no changes to the functional observational battery, no changes in mean daily food consumption or body weight development, no effects upon hematology, clinical biochemistry or urinalysis parameters, no changes in mean absolute or relative organ weights, and no toxicologically relevant macroscopical or microscopical changes. Based on the results of this study, the NOEL and NOAEL are > or = 1000 mg/kg bw/day.

Justification for classification or non-classification